Usefulness of Implementation Outcome Scales for Digital Mental Health (iOSDMH): Experiences from Six Randomized Controlled Trials

Objectives: Measuring implementation outcomes for digital mental health interventions is essential for examining the effective delivery of these interventions. The “Implementation Outcome Scale of Digital Mental Health” (iOSDMH) has been validated and used in several trials. This study aimed to compare the iOSDMH for participants in six randomized controlled trials (RCTs) involving web-based interventions and to discuss the implications of the iOSDMH for improving the interventions. Additionally, this study examined the associations between iOSDMH scores and program completion rate (adherence). Methods: Variations in total scores and subscales of the iOSDMH were compared in six RCTs of digital mental health interventions conducted in Japan. The web-based intervention programs were based on cognitive behavioral therapy (2 programs), behavioral activation (1 program), acceptance and commitment (1 program), a combination of mindfulness, behavioral activation, and physical activity (1 program), and government guidelines for suicide prevention (1 program). Participants were full-time employees (2 programs), perinatal women (2 programs), working mothers with children (1 program), and students (1 program). The total score and subscale scores were tested using analysis of variance for between-group differences. Results: Total score and subscale scores of the iOSDMH among six trials showed a significant group difference, reflecting users’ perceptions of how each program was implemented, including aspects such as acceptability, appropriateness, feasibility, overall satisfaction, and harm. Subscale scores showed positive associations with completion rate, especially in terms of acceptability and satisfaction (R-squared = 0.93 and 0.89, respectively). Conclusions: The iOSDMH may be a useful tool for evaluating participants’ perceptions of features implemented in web-based interventions, which could contribute to improvements and further development of the intervention

Association of Paternity Leave with Impaired Father–Infant Bonding: Findings from a Nationwide Online Survey in Japan

Although the number of fathers taking childcare leave is increasing, the impact of paternity leave on father–infant bonding remains to be fully investigated. This study aimed to assess the association between paternity leave and father–infant bonding among fathers with children under two years old. A cross-sectional study was performed using data from the Japan COVID-19 and Society Internet Survey study, a nationwide online survey conducted between July and August 2021 (N = 1194). Father–infant bonding was assessed by the Japanese version of the Mother–Infant Bonding Scale (MIBS-J), which comprised two subscales (lack of affection (LA), and anger and rejection (AR)), with a higher score denoting poor bonding. Four hundred (33.5%) fathers self-reported taking childcare leave. Paternity leave was associated with higher total MIBS-J score and AR score after adjusting for covariates (coefficient 0.51; 95% confidence interval (CI) 0.06–0.96, coefficient 0.26; 95% CI 0.03–0.49, respectively), but not with LA score (coefficient 0.10; 95% CI −0.13–0.34). There was no trend in the association between paternity leave and total MIBS-J score by children’s age group (p for trend = 0.98). Paternity leave was associated with impaired bonding, especially with increased anger and rejection, among fathers with children under two years of age

Risk factors of paternal perinatal depression during the COVID-19 pandemic in Japan

Purpose The study aims to investigate risk factors of paternal perinatal depression during the COVID-19 pandemic. Methods We conducted an online cross-sectional study of 473 prenatal fathers and 1246 postnatal fathers in August 2021. We applied a modified Poisson regression to estimate relative risk ratios of possible factors for paternal perinatal depression (measured by Edinburgh Postnatal Depression Scale), sequentially introducing the following factors into the model: individual factors, interpersonal factors, obstetric/pediatric factors, and service utilization factors. Results Prenatal fathers with the following risk factors were at an increased risk for having depressive symptoms: adverse childhood experiences (risk ratio; RR 1.61), past depression (RR 1.63), fear of COVID-19 (RR 2.09), lower social support (RR 1.91), low family resources (RR 1.95), and intimate partner violence (IPV) victimization (RR 1.29). Postnatal fathers having the following risk factors were at an increased risk for having depressive symptoms: past depression (RR 1.67), fear of COVID-19 (RR 1.26), low family resources (RR 1.85), IPV victimization. (RR 1.18), and preterm birth (RR 1.18). Conclusion The study showed risk factors such as past history of depression, high fear of COVID-19, low family functionality, and IPV victimization were associated with perinatal depressive symptoms. The findings should contribute to future directions of interventions for paternal perinatal mental health

Association between Poverty and Refraining from Seeking Medical Care during the COVID-19 Pandemic in Japan: A Prospective Cohort Study

This limited study examined how low household income affected avoidant behaviors to seek medical care during the pandemic. We investigated an association between household income below the relative poverty line and refraining from seeking medical care (RSMC) in a longitudinal study during the COVID-19 pandemic. We conducted an analysis of a population-based internet cohort in Japan. Individuals aged 20 to 79 years old living in Japan participated in the internet surveys between 2020 and 2021. The primary outcome was the RSMC of regular visits and new symptoms in 2021. A total of 19,672 individuals were included in the analysis. Household income below the relative poverty line in 2020 was significantly associated with refraining from seeking regular medical visits for men and women (for men, odds ratio: 1.28; confidence interval: 1.19, 1.83; for women, odds ratio: 1.42; confidence interval: 1.14, 1.82) in 2021, after accounting for RSMC in 2020. Relative poverty in 2020 was also associated with the RSMC of new symptoms among men (for males, odds ratio: 1.32; confidence interval: 1.05, 1.66) in 2021 after adjusting for covariates. The study suggested the need to alleviate the financial burden of vulnerable people seeking medical care and advocate for making necessary medical visits, even in a pandemic

Implementation outcome scales for digital mental health (iOSDMH): Scale development and cross-sectional study

Background: Digital mental health interventions are being used more than ever for the prevention and treatment of psychological problems. Optimizing the implementation aspects of digital mental health is essential to deliver the program to populations in need, but there is a lack of validated implementation outcome measures for digital mental health interventions. Objective: The primary aim of this study is to develop implementation outcome scales of digital mental health for different levels of stakeholders involved in the implementation process: Users, providers, and managers or policy makers. The secondary aim is to validate the developed scale for users. Methods: We developed English and Japanese versions of the implementation outcome scales for digital mental health (iOSDMH) based on the literature review and panel discussions with experts in implementation research and web-based psychotherapy. The study developed acceptability, appropriateness, feasibility, satisfaction, and harm as the outcome measures for users, providers, and managers or policy makers. We conducted evidence-based interventions via the internet using UTSMeD, a website for mental health information (N=200). Exploratory factor analysis (EFA) was conducted to assess the structural validity of the iOSDMH for users. Satisfaction, which consisted of a single item, was not included in the EFA. Results: The iOSDMH was developed for users, providers, and managers or policy makers. The iOSDMH contains 19 items for users, 11 items for providers, and 14 items for managers or policy makers. Cronbach α coefficients indicated intermediate internal consistency for acceptability (α=.665) but high consistency for appropriateness (α=.776), feasibility (α=.832), and harm (α=.777) of the iOSDMH for users. EFA revealed 3-factor structures, indicating acceptability and appropriateness as close concepts. Despite the similarity between these 2 concepts, we inferred that acceptability and appropriateness should be used as different factors, following previous studies. Conclusions: We developed iOSDMH for users, providers, and managers. Psychometric assessment of the scales for users demonstrated acceptable reliability and validity. Evaluating the components of digital mental health implementation is a major step forward in implementation science

Usefulness of Implementation Outcome Scales for Digital Mental Health (iOSDMH): Experiences from Six Randomized Controlled Trials

Objectives: Measuring implementation outcomes for digital mental health interventions is essential for examining the effective delivery of these interventions. The “Implementation Outcome Scale of Digital Mental Health” (iOSDMH) has been validated and used in several trials. This study aimed to compare the iOSDMH for participants in six randomized controlled trials (RCTs) involving web-based interventions and to discuss the implications of the iOSDMH for improving the interventions. Additionally, this study examined the associations between iOSDMH scores and program completion rate (adherence). Methods: Variations in total scores and subscales of the iOSDMH were compared in six RCTs of digital mental health interventions conducted in Japan. The web-based intervention programs were based on cognitive behavioral therapy (2 programs), behavioral activation (1 program), acceptance and commitment (1 program), a combination of mindfulness, behavioral activation, and physical activity (1 program), and government guidelines for suicide prevention (1 program). Participants were full-time employees (2 programs), perinatal women (2 programs), working mothers with children (1 program), and students (1 program). The total score and subscale scores were tested using analysis of variance for between-group differences. Results: Total score and subscale scores of the iOSDMH among six trials showed a significant group difference, reflecting users’ perceptions of how each program was implemented, including aspects such as acceptability, appropriateness, feasibility, overall satisfaction, and harm. Subscale scores showed positive associations with completion rate, especially in terms of acceptability and satisfaction (R-squared = 0.93 and 0.89, respectively). Conclusions: The iOSDMH may be a useful tool for evaluating participants’ perceptions of features implemented in web-based interventions, which could contribute to improvements and further development of the intervention

Psychological intervention for universal prevention of antenatal and postnatal depression among pregnant women:protocol for a systematic review and meta-analysis

BACKGROUND: Prevention of antenatal and postnatal depression is crucial, given its high prevalence and severe consequences. Although several systematic reviews and meta-analyses have examined the effects of psychological interventions on the population at risk for perinatal depression, few studies have focused on universal prevention and none have focused specifically on universal prevention in pregnancy. The aim of this study is to examine the effects of psychological interventions with a universal prevention focus on perinatal depression during pregnancy by performing a systematic review and meta-analysis based on both the latest articles and a broader literature search. METHODS: The literature search will be conducted using the Cochrane Controlled Register of Trials (CENTRAL), Embase, PubMed and PsycINFO, from inception onwards. Randomized controlled trials that examined the association between psychological interventions and universal prevention of antenatal and postnatal depression among pregnant women will be included. Study selection, data collection, quality assessment, and statistical syntheses will be conducted following a priori defined methods in the protocol. DISCUSSION: The findings of this systematic review and meta-analysis will have both clinical and political importance in the context of perinatal mental health. In addition, this study will promote future studies and clarify the direction of research on universal prevention of perinatal depression. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019118041

Psycho-educational interventions focused on maternal or infant sleep for pregnant women to prevent the onset of antenatal and postnatal depression:A systematic review

Aims: This systematic review aimed to evaluate randomized controlled trials (RCTs) to examine the effect of maternal and infant sleep intervention during women's pregnancy for the purpose of preventing perinatal depression. Method: A systematic search (from inception to January 28, 2019) for RCTs using five electronic databases—the Cochrane Controlled Register of Trials (CENTRAL), Embase, PubMed, PsycINFO, and Ichushi Web (Japan Medical Abstracts Society)—was conducted. Twelve investigators independently conducted initial screenings based on title and abstract, and then, two researchers performed full-text reviews one by one. A meta-analysis would be conducted if at least three studies were found. However, only two articles that met inclusion criteria, and narrative data synthesis was conducted for these two articles. The study protocol has been registered at PROSPERO (CRD42019119999). Result: A total of 13 654 studies were initially searched. After removing duplicates, 10 547 studies were screened, and finally, two studies met the inclusion criteria. In both studies, the intervention was a one-time face-to-face session during pregnancy to deliver the behavioral knowledge and skills for optimizing sleep hygiene for both infant and mother. Effectiveness of the intervention in improving maternal mood was not significant in one study. In the other, there was a significant difference in maternal mood between the intervention and control group. No mood comparison was made between baseline and postintervention. Conclusion: This study found limited evidence to support the effectiveness of sleep intervention for all pregnant women, which means “universal intervention,” to protect maternal mental health. Further well-designed RCTs are needed to confirm these findings